NCT02270294

Brief Summary

The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2016

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

October 14, 2014

Last Update Submit

April 1, 2018

Conditions

Ischemic Stroke

Keywords

Ischemic strokeThai traditional massageVascular functionCerebral blood flowCerebrovascular reactivity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cerebrovascular reactivity

    \- Cerebrovascular reactivity or cerebral CO2 reactivity test will be assessed using the ultrasound equipment (CX50, Philips, USA). Blood flow velocity (BFV) of the middle cerebral artery (MCA) will be measured during normocapnic, hypocapnic, and hypercapnic states. Subjects will be asked to wear nose clips and breathe only through a mouthpiece. Baseline (3 minutes) recordings will be taken during spontaneous breathing of room air and then subjects underwent 1 minute of maximal voluntary hyperventilation with a duty cycle of 1 second. The MCA-BFV will be recorded during the last 20 seconds of hyperventilation. After that, subjects will be asked to breathe air containing a mixture of 5 % CO2 and 21 % O2 balanced with nitrogen spontaneously for 3 minutes and the MCA-BFV will be recorded during the last minute of hypercapnia.

    baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.

Secondary Outcomes (4)

  • Change from baseline in stress indicators

    Baseline, Post-test (immediately: 0 min after finish massage intervention)

  • Change from baseline in stress indicators

    Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.

  • Change from baseline in Peripheral arterial stiffness

    Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.

  • Change from baseline in blood chemistry

    baseline, Post-test (immediately: 0 min after finish massage intervention)

Study Arms (2)

Thai traditional massage

EXPERIMENTAL
Other: Thai traditional massage

No massage

SHAM COMPARATOR
Other: No massage

Interventions

Thai traditional massageOTHER

Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.

Also known as: Thai massage
Thai traditional massage
No massageOTHER

The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.

No massage

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A single ischemic stroke with Middle cerebral artery (MCA) stenosis
  • Men or women age 50-80 years
  • Physician's approvals to participate the study
  • Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment
  • The modified rankin scale level is 2 or 3

You may not qualify if:

  • History of serious diseases
  • Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis)
  • Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D)
  • Neurological disorders (Peripheral neuropathy, Parkinson)
  • Respiratory diseases (Chronic Obstructive Pulmonary Disease)
  • Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease)
  • Medical condition precluding taking Anticoagulant and Statin drug
  • Temporal window were not found

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Medicine, Thai Traditional

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medicine, TraditionalComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DSuksom

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

October 31, 2015

Study Completion

August 3, 2016

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations

TH(1)